MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGG

Catalog Number 30320

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomérieux to report the occurrence a false negative patient result in association with the vidas® lyme igg assay (ref.30320).The initial result was 0.19 (negative); repeat result was 0.26 (positive).The customer also indicated that qc is inconsistent for the lyme igg assay.There is no indication or report from the laboratory or a physician that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux requested strain submittal from the customer.A biomérieux internal investigation has been initiated.Note: reference 30320 (vidas lyme igg) is not registered in the united states.The u.S.Similar device is product reference 417401 (vidas lyme igg ii).

Manufacturer Narrative

An internal investigation was performed for a false negative result in association with vidas® lyme igg (1006179040).Complaint trending analysis: four complaints for the external quality control issue on vidas lyg batch 1006179040/181125-0 linked to the accurun quality control sample.One complaint for sensitivity issue on vidas lyg batch 1006179040/181125-0 linked to the patient clinical context.There is neither capa nor non conformity linked to this issue.Quality control records: the analysis of the batch history records of vidas lyg batch 1006179040/181125-0 showed no anomaly during the manufacturing, control and packaging processes.Study of internal samples control charts: this analysis was carried out on six internal positive controls that included three samples with high test values and three samples with test values close to the cut-off for vidas lyg batch 181125-0 compared to three other batches (180802-0, 180929-0 and 190104-0).All the results were within acceptable ranges and vidas lyg batch 1006179040/181125-0 conformed to the product specifications.Tests performed internally: biomérieux tested six internal samples from the activity panel on vidas lyg batch 1006179040/181125-0 compared to two other batches manufactured using different raw material.Although, vidas lyg batch 1006179040/181125-0 gives slightly lower test values, all the results are within the acceptable ranges.The customer's accurun sample gave positive results (between 3.19 and 4.21 tv) with the three vidas lyg batches (181125-0, 180929-0 and 190821-0).Testing reproduced the lower result observed by the customer with vidas lyg batch 1006179040/181125-0.The patient sample identified (b)(6) is positive with vidas lyg batches 180929-0 and 190821-0 but close to the cut-off (0.18 tv) with a negative interpretation when testing with vidas lyg batch 1006179040/181125-0.Testing reproduced a negative result observed by the customer when using vidas lyg batch 1006179040/181125-0.Tests performed by an external laboratory (biomnis): the patient sample (b)(6) gave a positive interpretation with presence of bands anti vlse, anti p41 et anti p18.The analysis performed showed that vidas lyg batch 1006179040/181125-0 was in the trend of the parameter regarding all the required criteria.Although vidas lyg batch 1006179040/181125-0 had a trend to give lower results, all the results were within acceptable ranges and we did not observed any degradation of its activity compared to its release.

• Brand Name: VIDAS® LYME IGG
• Type of Device: VIDAS® LYME IGG
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 7961108
• MDR Text Key: 123569460
• Report Number: 3002769706-2018-00211
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2018
• Device Catalogue Number: 30320
• Device Lot Number: 1006179040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1